Combined eye and ear drops 5 ml
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Active ingredients
Ciprofloxacin + Dexamethasone
Release form
Drops
Composition
Active ingredient: Dexamethasone (dexamethasone) + ciprofloxacin (ciprofloxacin) Active ingredient concentration (mg): ciprofloxacin (in the form of hydrochloride) 3 mg, dexamethasone 1 mg
Pharmacological effect
A drug with antibacterial and anti-inflammatory effects for local use in ophthalmology and ENT practice. The therapeutic effect of the drug Combin-Duo is due to the antibacterial effect of ciprofloxacin and the anti-inflammatory effect of dexamethasone. Ciprofloxacin is an antibacterial drug from the group of fluoroquinolones, has a broad spectrum of action, has a bactericidal effect. The drug inhibits the enzyme DNA gyrase of bacteria, as a result of which DNA replication and the synthesis of bacterial cellular proteins are impaired. Ciprofloxacin acts both on reproducing microorganisms and on those at rest. Active against gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp. (indole-positive and indole-negative), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multo chydehytea, 2014, imeratidea Ia Ia, Iadena stuppiati, Haemophilus stif. Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp., Brucella spp., Chlamydia spp .; Gram-positive microorganisms: Staphylococcus spp., Streptococcus pyogenes, Streptococcus agalactiae, Сrynebacterium diphtheriae, Listeria monocytogenes. Dexamethasone - synthetic GCS. When applied topically, the therapeutic activity of dexamethasone is due to anti-inflammatory, anti-allergic and anti-proliferative effects. It reduces the permeability and proliferation of capillaries, local exudation, cellular infiltration, phagocytic activity, collagen deposition and fibroblast activity, inhibits the formation of scar tissue. Thus, dexamethasone reduces the main symptoms of inflammation.
Pharmacokinetics
When used in ophthalmology, ciprofloxacin penetrates well into various tissues of the eye, with the exception of the lens. Cmax occurs within 30 minutes, the greatest concentration is observed in the moisture of the anterior chamber. Observed systemic reabsorption. However, the drug concentration reached in the blood is well below the detection limit and has no clinical significance. Dexamethasone after instillation into the conjunctival sac penetrates well into the corneal epithelium and conjunctiva; while in the aqueous humor the eyes are reachedtherapeutic concentrations; in case of inflammation or damage to the mucous membrane, the rate of penetration increases. When used in otorhinolaryngological practice, the introduction of a fixed combination of ciprofloxacin and dexamethasone into the ear canal Cmax for ciprofloxacin is 1.55 ng / l, and for dexamethasone 0.86 ng / l. T1 / 2 ciprofloxacin - 2.9 h, dexamethasone - 2.8 h. Part of the drug as an auxiliary component of hydroxypropyl beta cyclodextrin contributes to the long-term preservation of the active substance on the front surface of the eye, thereby increasing the effectiveness and duration of the drug.
Indications
Infectious and inflammatory diseases of the eye and its appendages: acute and subacute conjunctivitis; keratitis; anterior uveitis; blepharitis and other inflammatory diseases of the eyelids; prevention and treatment of infectious complications after injuries of the eye and its appendages and during operations on the eyeball. Infectious-inflammatory diseases of the ear: acute otitis externa; acute otitis media with eardrum shunt; acute otitis media with granulations and otorrhea in the presence of an eardrum shunt.
Contraindications
Herpetic keratitis and other viral lesions of the cornea and conjunctiva; eye tuberculosis; fungal eye disease; viral infections of the ear canal; perforation of the eardrum; children up to 18 years; pregnancy; lactation period (breastfeeding); Hypersensitivity to the active substances or to any of the auxiliary ingredients of the drug.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Use of the drug is contraindicated during pregnancy and lactation.
Dosage and administration
Instill 1-2 drops in the conjunctival sac.
Side effects
On the part of the organ of vision: corneal infiltrates, burning, redness, itchy eyes, conjunctivitis, keratitis, periocular edema, foreign body sensation in the eye, photophobia, blurred vision, dry eye, eyelid edema, conjunctival hyperemia, glaucoma and damage to the optic nerve, dehydration of vision and narrowing of the visual fields, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and / or perforation of the eyeball. On the part of the organ of hearing: discomfort and pain in the ear, itching in the ear, ear congestion. Others: swelling of the face a, slowing wound healing, taste perversions, skin rash.
Overdose
Symptoms: local - the occurrence of point keratitis, erythema, increased tearing, swelling and itching of the eyelids. There is no data on systemic manifestations of overdose. Treatment: there is no specific antidote. You should wash your eyes with water, discontinue the drug and prescribe symptomatic therapy.
Interaction with other drugs
Systemic absorption when administered locally is insignificant; therefore, the likelihood of drug interactions is extremely low. Drugs that induce CYP 3A4 isoenzyme activity (barbiturates, phenytoin, carbamazepine, rifampicin) can increase GCS metabolism. Drugs inhibiting CYP 3A4 activity (ketoconazole, macrolides), can cause an increase in plasma corticosteroids. Dexamethasone is a moderate inducer of CYP3A4. Co-administration with drugs metabolized by CYP3A4 (erythromycin) can increase their clearance, reducing their concentration in plasma. When combined with ciprofloxacin with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed it can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolylpenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.
special instructions
Prolonged use of eye drops can lead to an increase in intraocular pressure, followed by damage to the optic nerve, a decrease in acuity and visual fields, as well as the formation of posterior subcapsular cataracts. When using Combine-Duo for more than 10 days, it is necessary to control intraocular pressure. In case of acute purulent eye infections, corticosteroids may worsen or mask the symptoms of the disease. Long-term use of the drug may decrease the immune response and lead to the development of a secondary infection of the eye. Patients using contact lenses should take off them before instillation of the drug and put on again only after 20 minutes, since the preservative contained in the preparation may have an adverse effect on eye tissue. The bottle should be closed after each use.You should not touch the eye with a pipette tip. Before using the ear drops, you should reorganize the ear canal (wash and dry the external ear canal). Before the instillation of the drug in the external ear canal, warm it up to body temperature by holding it in your hands for 1-2 minutes .It is necessary to lie on one side or throw back the head to facilitate the instillation. To drip into the external ear canal the specified number of drops. Let the drops flow into the ear canal, pulling the earlobe down and back. Keep your head in the upturned position for about 2 minutes. It is possible to place a wadded turunda in the external auditory canal. Influencing the ability to drive a motor vehicle and control mechanisms